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OpenTrials
Completed

NCT Number: NCT02433496

Physician Coaching to Reduce Opioid-related Harms

This project pilot tests an innovative clinical guideline translation and physician coaching model to promote adherence to evidence-based guidelines for the prescribing of opioid pain medications in primary care settings.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

About this study

This project addresses the urgent need to promote the adoption of evidence-based practices in healthcare by pilot-testing an innovative implementation strategy. The implementation strategy aims primarily to reduce variation in opioid prescribing practices for chronic pain in primary care settings.

The standard approach to improving medical practice involves groups of clinical experts reviewing the literature to produce clinical guidelines based on scientific evidence, and disseminating those guidelines by publishing them in medical journals. A clinical guideline has been developed for opioid prescribing for chronic non-cancer pain using this type of approach. The implementation strategy for promoting uptake of the guideline in primary care settings tested in this study consists of three innovations: (1) a process for translating clinical guidelines into a checklist-based implementation guide for clinicians, (2) a physician peer coaching model, and (3) implementation support using tools from systems engineering. This project teams the experts who developed the guideline for opioid prescribing with experts in implementation science and primary care to translate the guideline into an actionable, checklist-based implementation guide. If the implementation strategy is effective in this pilot test, it will be used in a larger cluster-randomized trial to test it against other approaches to evidence-based practice adoption.The long-term goal of this research is to improve the adoption of evidence-based practices in primary care by producing a generalizable model of change.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

At each of the 4 coaching intervention sites, we aim to recruit between 3-7 clinical care providers with prescribing authority (e.g., primary care physicians, mid-level practitioners, etc.) to participate in interviews and focus groups. All clinic staff (e.g., medical assistants, office staff) are welcome to participate in coaching site visits and follow up correspondence, but only staff with prescribing authority will be considered research participants.

Exclusion criteria

  • Residents will be excluded.

Treatment and study plan

Physician coaching

Other

The coach will present the latest research on the benefits and risks of long-term opioid use. The presentation will be followed by a brainstorming exercise where the coach joins the clinic team in experiencing clinical practices from the perspective of a patient with chronic pain. The coach will help the clinic team flowchart clinical workflows and determine the best course for implementing aspects of a checklist-based implementation guide developed to support adoption of the guidelines for opioid prescribing.

The coach will help the team implement ideas using Plan-Do-Study-Act change cycles. The coach will maintain monthly email and phone contact with the clinic lead and clinic team after the initial site visit to monitor implementation progress and offer advice.

Primary outcomes

  1. Overall Rate of Opioid Prescribing

    Time frame: Up to 3 years

    The proportion of patients with a chronic pain diagnosis receiving daily opioids.

Secondary outcomes

  1. Rate of Opioid / Benzodiazepine Co-prescribing

    Time frame: Up to 3 years

    Proportion of patients with a chronic pain diagnosis receiving daily opioids and benzodiazepines concurrently.

  2. Urine Drug Screening Rate

    Time frame: Up to 3 years

    Proportion of opioid patients completing urine drug screens prior to and during the study intervention

  3. Mental Health Screening Rate

    Time frame: Up to 3 years

    Proportion of opioid patients screened for mental health/substance use problems

  4. Use of Pain Management Agreements

    Time frame: Up to 3 years

    Proportion of opioid patients signing pain management agreements

  5. High-dose Patients

    Time frame: Up to 3 years

    Proportion of opioid prescriptions above 120 mg daily morphine equivalent

  6. Provider Drop-out Rate

    Time frame: 3 months

    Number and percentage of providers who drop out of study at 3 months

  7. Participating Patient Demographics

    Time frame: Up to 3 years

    Characteristics of participating patients vs. general patient population (race, gender, ethnicity)

  8. Participating Clinic Characteristics

    Time frame: Up to 12 months

    Characteristics of participating clinics vs. non-participating clinics (number of patients, number of providers, overall opioid prescribing rate)

  9. Participating Staff Characteristics

    Time frame: Up to 12 months

    Characteristics of participating staff (profession)

  10. Intervention Fidelity

    Time frame: Up to 12 months

    Total hours of coaching delivered/received among all clinics that received physician coaching.

  11. Intervention Cost

    Time frame: Up to 12 months

    Total cost of coaching intervention among all clinics that received physician coaching. At clinic level.

  12. Proportion With MEDD >120 mg

    Time frame: Up to 12 months

    The proportion of patients who have consistent opioid Rx above a morphine equivalent daily dose about 120 mg.

  13. Average Morphine Equivalent Daily Dose (MEDD)

    Time frame: Up to 12 months

    The average MEDD in milligrams for patients with consistent opioid Rx.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Center for Health Enhancement System Studies
  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 5, 2015
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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